BMO Family Office
The global race for a vaccine remains in full swing, and six primary technologies are being explored by clinical COVID vaccine programs. From a technical perspective, they include inactivated virus; DNA; Protein Subunit; Non-replicating viral Vector; RNA; and VLP (Virus Like Particles). At this stage two of these technologies (Non Replicating Viral Vector and RNA) and the three associated programs are furthest along in their research – AstraZeneca (AZN) /Oxford, Moderna (MRNA) and Pfizer (PFE) /BioNTech (BNTX).
Since the bottom of the equity markets in March, the biotech industry has been a top performer (Chart 1). This is not surprising given the intensive interest in health care businesses, most specifically those involved in combating the Coronavirus threat.
And thus far the investor sentiment seems justified from a scientific perspective, given the significance research advances made over the past several months. The most important recent news came from AstraZeneca/Oxford, when Phase I data published in The Lancet demonstrated a similar antibody response in vaccinated patients (after a month) to that seen in patients previously infected with the SARS-CoV-2 virus. A robust cellular response was noted, and neutralising activity to the live virus was seen in 95% of patients who received one vaccine dose (after one month) and 100% of patients who received a 2nd boost. The results were positive, but did fall short of the neutralising antibody levels seen in the Moderna and Pfizer/BioNtech studies. However, it is important to note that there is currently limited consensus on what levels of neutralising antibodies are needed to achieve successful long-term clinical outcomes, as well as how critical cellular responses will be in generating durable immunity. Of course the AstraZeneca/Oxford study is only one of the trials currently underway. Two other candidates are also at the forefront.
Moderna’s RNA Vaccine (mRNA-1273)
Moderna was the first company to enter clinical development in the U.S., with its Phase 1 trial initiated in March, followed by Phase 2 in May.
In May, they announced positive interim Phase 1 data, though it contained limited information.
Phase 2 enrollments and the finalization of the Phase 3 trial protocol was announced in mid-July, based on FDA feedback.
Phase 3 trials are scheduled to start on July 27, 2020, enrolling 30,000 subjects in the U.S., and Moderna has communicated that they expect emergency use authorization to be available in the fall of 2020.
Pfizer is developing its mRNA vaccine with BioNTech (BNTX) of Germany. While Moderna is testing a single vaccine candidate, Pfizer has brought four separate versions of its vaccine into clinical trials. Phase 1 interim results from the lead program (BNT162b1 RBD modRNA) were announced in early July.
On July 13, the FDA has granted fast track designations to the two lead vaccine programs (BNT162b1 and BNT162b2) out of the four total vaccines.
The next step in the trial is to identify a lead candidate following further data, and also finalize the dose level for a global Phase 2b/3 safety and efficacy study. If all goes well, that study may begin as early as later this month, pending regulatory approval.
Most recently, on July 22, an agreement with the U.S. Government was announced for up to 600M doses. The government will pay the companies $1.95B when the first 100M doses are received, following FDA authorization or approval, with an option for up to an additional 500M doses thereafter. If the ongoing studies are successful, PFE/BNTX plans to seek accelerated approval as early as October 2020.
With governments, businesses and academic institutions around the world acutely focused on vaccine development, standard drug study timelines are being significantly condensed. The clinical development process for a typical novel preventive vaccine would take years, while many have suggested current efforts could lead to a drug being produced in as little as 9-12 months (i.e. sometime in the fall of 2020).
While the progress made to date is another testament to human ingenuity, it is important to view any projected approval timelines with some amount of skepticism. Unlike most medications, which are given to ill patients, vaccines are received by healthy individuals, thus the margin of safety needs to be very high. There is reason to be hopeful - particularly as so many programs have been fast-tracked by the FDA – but the reality of the availability, effectiveness, and utility may fall short of an immediate, universal cure. That said, we are optimistic on the future, and do believe the initial vaccines should be broadly available to the public sometime in the first half of 2021. Though it is important to note that whichever comes to market first is unlikely to be the last, or ultimately the best.
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